Methods and apparatus for preventing migration of sutures through transosseous tunnels

ABSTRACT

An improved method for attaching soft tissue to bone by passing a suture through an opening in the bone, e.g., a transosseous tunnel, and affixing the soft tissue with the suture. The improvement, for preventing the suture from migrating through the bone at the end of the opening, includes placing a eyelet into an end of the bone opening and passing the suture through the eyelet, as well as through the opening in the bone, in order to affix the soft tissue to the bone with the suture.

This application is a continuation-in-part of U.S. application Ser. No.08/163,130, filed Dec. 6, 1993, which is a continuation-in-part of U.S.application Ser. No. 07/765,445, filed Sep. 25, 1991, and issued as U.S.Pat. No. 5,268,001, which is a continuation-in-part of U.S. patentapplication Ser. No. 07/588,055, filed Sep. 25, 1990, now U.S. Pat. No.5,088,147. The entire contents of these applications are incorporatedherein by reference.

BACKGROUND OF THE INVENTION

This invention pertains to surgical systems and, more particularly,methods and apparatus for attaching tissue to bone. The invention hasapplication in, for example, rotator cuff repair.

It is not uncommon for tendons and other soft tissues to tear or todetach from bone. Athletes, for example, often suffer "rotator cuff"tears, in which the supraspinatus tendon separates from the humerus,causing pain and loss of ability to elevate and externally rotate thearm. Complete separation can occur if the should is subjected to grosstrauma. Typically, however, the tear begins as a small lesion,especially, in older patients.

To repair a torn rotator cuff, surgeons must reattached thesupraspinatus tendon to the humerus. Traditionally, this has been doneby boring several holes obliquely through the greater tuberosity, thatis, the bony structure on the outer side of the head of the humerus.Sutures are then passed through these holes, or transosseous tunnels, inorder to secure the tendon.

Though use of such sutures to anchor the tendon have been referred to asthe "gold standard," it has been shown that the sutures migrate throughthe bone itself, particularly, along the upper edge of the openings thatdefine the ends of transosseous tunnels on lateral cortex of the greatertuberosity. This is particularly pronounced in older patients, whosebone structures tend to be weaker and, therefore, less resistant todegradation under the force of the sutures. On prior art solution hasbeen to augment the edges of the transosseous tunnels by affixingplatelike pieces; see, Gerber et al, "Mechanical Strength of Repairs ofthe Rotator Cuff,"Journal of Bone Joint Surgery, v. 76, n. 3, p. 371-380(May 1994). See France et al, "Biomechanical Evaluation of Rotator CuffFixation Methods," The American Journal of Sports Medicine, v. 17, n. 2,pp. 176 et seq.

Drawbacks of plate-like augmentation of the greater tuberosity are thedifficulties in positioning and affixing the plates. Though endoscopicsurgery is generally preferred, use of augmentation plates necessitatesthat rotator cuff repair be performed by open surgery. Moreover, theplates must be affixed to the bone by surgical glues in order to avoidrisk that they will migrate from the site in the event of suturebreakage.

An object of this invention is to provide improved surgical systems and,more particularly, methods and apparatus for attaching tissue to bone.

Another object of this invention is to provide improved methods andapparatus for rotator cuff repair.

A related object of the invention is to provide improved methods forreinforcing the edges of transosseous tunnels against force of sutures.

SUMMARY OF THE INVENTION

The above objects are among those met by the invention, which providesin one aspect an improvement on a method for attaching soft tissue tobone by passing a suture through an opening in the bone, e.g., atransosseous tunnel, and affixing the soft tissue with the suture. Theimprovement, for preventing the suture from migrating through the boneat the end of the opening, includes placing a eyelet into an end of thebone opening and passing the suture through the eyelet, as well asthrough the opening in the bone, in order to affix the soft tissue withthe suture.

In a related aspect, the invention provides a method as described abovefor use in attaching the spinatus tendon to the humerus bone by placingan eyelet into an end of a transosseous tunnel and passing the suturethrough the eyelet, as well as through the tunnel, in order to affix thetendon to the humerus.

Further aspects of the invention provides methods as described above, inwhich the eyelet is screwed, or fit by interference, into the boneopening. In still further related aspects, the bone opening is expandedprior to placement of the eyelet.

In another aspect, the invention provides an apparatus for use inrotator cuff repair for reinforcing a transosseous tunnel to preventmigration of a suture through bone at the end of the tunnel. Theapparatus comprises an eyelet arranged for placement within the end ofthe tunnel, or within an expanded hole formed at the end of the tunnel.The eyelet has a channel therethrough for passage of the suture and caninclude a flanged head to prevent the eyelet from being forced too farinto the tunnel.

Related aspects of the invention provide an apparatus as described abovein which the eyelet is threaded for screwing into bone on the inside ofthe wall of the hole or, alternatively, is arranged for interference fitwith that inside wall.

Still another aspect of the invention provides an improvement on amethod for attaching soft tissue to bone by passing a suture through anopening in the bone and affixing the soft tissue with the suture. Theimprovement, for reinforcing the bone opening, includes placing anexpandable member into an end of the bone opening and inserting aninsertion element into a channel that passes through the expandablemember. A portion of the insertion element has an outer diameter greaterthan an inner diameter of at least a portion of the channel in theexpandable member, so that insertion of the insertion element into theexpandable member causes the expandable member to expand to obtain apressure fit with the bone opening. The improvement further includespassing the suture through an channel of the insertion element, as wellas through the opening in the bone, in order to affix the soft tissuewith the suture.

Another aspect of the invention provides a method as described above inwhich the expandable member is substantially cylindrical and has anaxial channel that extends between its proximal and distal ends.According to this embodiment, the insertion element is likewise elongateand has an axial channel extending between its proximal and distal ends.

In yet another aspect, the methods described above are adapted forrotator cuff repair. Accordingly, the step of placing the expandablemember into the end of the bone opening comprises placing that memberinto the end of a transosseous tunnel in the humerus.

Yet another aspect of the invention provides methods as described abovein which an emplacement element is used to place an expandable memberinto the end of the bone opening. In a related aspects, the emplacementelement is frangibly attached to the expandable member such thatapplication of force to the insertion element breaks the frangibleattachment between those elements after that force has caused theinsertion element to expand the expandable member.

Advantages of the invention include the ability to install thereinforcing eyelet via endoscopic surgery, as well as open surgery.

These and other aspects of the invention are evident in the drawings andin the description that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the invention may be attained byreference to the drawings, in which:

FIG. 1A depicts a partially torn rotator cuff;

FIG. 1B depicts the rotator cuff of FIG. 1A repaired in accord withprior art surgical techniques;

FIG. 2 depicts a surgical rotator cuff repaired according to theinvention;

FIG. 3A-3E depict an eyelet according to the invention and its use inrotator cuff repair according to the invention; and

FIGS. 4-7 depict further eyelets according to the invention.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT

FIG. 1A depicts a partially torn rotator cuff. In the illustration, theglobular head 10 of humerus 12 rests in the glenoid cavity 14 formed bythe scapula 16. The supraspinatus muscle 18 traverses the scapular spine(not shown) and converges into a tendon 19 (undifferentiated in theillustration), then end of which is normally fully inserted into a facetof the greater tuberosity 22. A partial tear rotator cuff tear resultswhen a portion 24 of the tendon 19 detaches from the greater tuberosity22, as shown in the illustration.

FIG. 1B illustrates the rotator cuff of FIG. 1A repaired in accord withthe prior art suturing technique, in which the tendon 19 is resecured tothe humerus by a suture 26 passed through a transosseous tunnel 28 boredobliquely through the greater tuberosity 22. A further understanding ofthe prior art suturing technique may be attained by reference to Gerber,et al, "Mechanical Strength of Repairs of the Rotator Cuff," Journal ofBone and Joint Surgery, v. 76-B, no. 3 (May 1994), at pp. 371, et seq.,the teachings of which are incorporated herein by reference.

Though FIG. 1B shows use of only a single transosseous tunnel andsuture, multiple tunnels and sutures are typically used, as discussed inthe aforementioned prior art reference. Each suture can be loopedsuperiorly (i.e., over the greater tuberosity), passed through thetendon and tied to itself. Alternatively, pairs of adjacent sutures canbe tied together between the exit holes on the lateral cortex.

FIG. 2 illustrates a modified suturing technique according to theinvention. The modification comprises use of a bone "eyelet" 32 toreinforce the opening 30 at the end of transosseous tunnel 28 on thelateral cortex of the greater tuberosity 22. This prevents migration ofthe suture 26 through the upper edge of the opening 30. Such migrationhas been discovered to result from repeated loading of the suture duringuse of the shoulder.

The eyelet 32 comprises a cylinder, or other such solid geometric shape(e.g., parallelapiped), suitable to be embedded into the humerus 12 and,particularly, the greater tuberosity 22, as shown. The eyelet 32includes a cannula 34, which is aligned with the transosseous tunnel 28,through which suture 26 passes. The eyelet 32 also preferably includes ahead 36 that protrudes above the bone surface. This head 36 is flangedto prevent the eyelet 32 from being driven too far into the opening 30and, more particularly, to prevent the head from being driven below thebone surface on emplacement or as a result of forces exerted by thesuture 26.

The eyelet 32 is threaded into transosseous tunnel 28 or is held byinterference fit, surgical epoxy or, simply, by the force exerted bysuture 26. In instances where the eyelet 32 requires it, the end 30 ofthe tunnel 28 can be enlarged to facilitate embedding the eyelet in thebone.

The eyelet 32 is comprised of a biocompatible material, i.e., a materialthat is chemically and biologically inert, such as, an implant gradehigh density polyethylene, low density polyethylene (PE 6010 and PE2030) and polypropylene (13R9A and 23M2: all made by Rexene, Dallas,Tex.). The eyelet 32 may also be comprised of a metal, such as, surgicalimplant grade stainless steel.

In one preferred embodiment, an eyelet 40 according to the invention isconstructed in a manner similar to the bone anchor of the type describedin copending, commonly assigned U.S. patent application Ser. No.08/163,130, filed Dec. 6, 1993, the teachings of which are incorporatedherein by reference. Such an eyelet is illustrated in FIGS. 3A-3E.

Referring to FIG. 3A, the eyelet 40 generally comprises an elongatedinsertion element 42 and an approximately cylindrical expandable member44. In its unexpended state, the expandable member 44 can be placed intoa bone hole 45, i.e., the end 30 of the transosseous tunnel 28 or anenlarged opening drilled into the bone at the end 30 of the tunnel 28.The expandable member 44 includes an axial channel 46, running end toend, for receiving the insertion element and for permitting passage of atransosseous suture.

As shown in the drawing, the outer diameter of at least a portion of theinsertion element 42 is greater than the inner diameter of at least aportion of the axial channel 46 of the expandable member 44.Accordingly, when the insertion element 42 is inserted into the axialchannel 46, the wider portion of the insertion element 42 exerts on thewalls of the expandable member 44 a force orthogonal to the channel 46.This outward force causes the expandable member 44 to expand against thewalls of bone hole 45, fixing the insertion element 42 within theexpandable member 44 and fixing the expandable member 44 in a pressurefit firmly within the opening 45.

The expandable member 44 includes an outer surface for securedengagement with an inner surface of the transosseous tunnel. That outersurface can be smooth or can be provided with a plurality of ridges 48,as shown. In particular, a preferred configuration includes a pluralityof annular ridges for engaging irregularities in the bone opening wallas the expandable member 44 deforms and conforms to the bone openingwall during and after expansion.

The expandable member 44 also includes a flanged head 49 disposed at theend to prevent the member 44 from being driven too far into thetransosseous tunnel on emplacement or as a result of forces exerted bythe transosseous suture. The head 49 preferably has a rounded outersurface to better distribute loads placed on it by the suture.

The insertion element 42 is a substantially elongated shape with anouter surface having one or more projections 50 for engagement with theinner surface of the axial channel 46 of expandable member 44. Theprojections 50 include portions with outer diameters that are greaterthan the inner diameter of the channel 46, as shown, so that they expandthe expandable member 44 upon insertion.

The insertion element 42 includes a channel 52 running the length of theelement, from end to end. The channel is sized to permit passage of asuture 26 of the type used for transosseous suture repair of the rotatorcuff.

The eyelet 40 is embedded in the transosseous tunnel 28 45 using anemplacement device of the type disclosed in aforementioned U.S. patentapplication Ser. No. 08/163,130. The device includes a cylindricalholding member 54 that holds the expandable member during emplacementvia a frangible junction 55. The holding member also retains theinsertion element 42 in alignment with the end of the expandable member44, as shown. The emplacement device further includes a plunger 56 thatexerts force on the insertion element 42 forcing it into thefrangibly-retained expandable member 44 and causing the holding memberto break-away from the expandable member 44, once insertion is complete.

A further understanding of the construction and operation of a boneanchor upon which the eyelet 40 is based may be attached by reference toaforementioned U.S. patent application Ser. No. 08/163,130, theteachings of which are incorporated herein by reference.

A surgical technique according to the invention proceeds in accord withconventional surgical techniques for suture rotator cuff repair. Oncethe transosseous tunnel 28 is drilled, however, the eyelet 40 isinstalled in order to reinforce the bone hole 45 and, particularly, theopening 30 at the end of transosseous tunnel 28 on the lateral cortex ofthe greater tuberosity 22. Particularly, as shown in FIG. 3A, the eyelet40 is positioned in the end of the bone hole 45. As shown in FIGS. 3B,the plunger 56 is used to force the insertion element 42 into theexpandable member 44, thereby fixing the insertion element 42 within theexpandable member 44 and fixing the expandable member 44 in a pressurefit firmly within the opening 45. As shown in FIG. 3C, once theinsertion element 42 is fully inserted, the continued force of theplunger 56 causes the holding member 54 to detach from the expandablemember 44 at the frangible junction 55. Once the eyelet is installed,the suture rotator cuff repair surgery is completed in the normalcourse, with the transosseous suture 26 being passed through the eyelet40 and, particularly, channels 46 and 52, as shown in FIG. 4D. Thecompleted repair,using eyelet 40, is shown in FIG. 3E.

Eyelets other than that shown in FIGS. 3A-3E may also be used topractice the invention. These are shown, for example, in FIGS. 4-7.

Referring to FIGS. 4A-4C, there is shown a threaded two-part eyelet 58having an insertion member 60 and an expandable member 62. The eyelet isused in the manner described above, however, the insertion member 60 isscrewed (rather then pushed) into the expander member 62 after thelatter has been placed in the bone hole. As shown in FIGS. 4B and 4C, asthe insertion element advances into the expander member, caming surfaces63 on the insertion element 60 force wings 64 on the expander member 62into walls of the bone hole. The expanded wings act as anchors,preventing the assembled unit (as shown in FIG. 4C) from moving withinthe hole. The expander element includes a flanged head region thatprevents the assembly from being driving further into the bone hole bythe force of the suture (not shown). As above, both the insertion member60 and expander element 62 are cannulated in order to permit the sutureto pass therethrough.

FIGS. 5A-5D show one-piece eyelets 70 according to the invention.Referring to FIGS. 5A and 5C, each eyelet 70 includes a head 72 toprevent the eyelet from being driven too far into the bone hole. Theeyelet 70 also includes a cannula 74 to permit passage of a suture. Onthe exterior surface of the body of the eyelet are one or more annularwings that anchor the eyelet within the bone hole. An embodiment withmultiple such wings 76 is shown, in cross-section, in FIG. 5A and, inside view, in FIG. 5B. An embodiment with a single such wing 76 isshown, in cross-section in FIG. SC and, in side view, in FIG. 5D. Thewings 76 are flexed or compressed inwardly on insertion of the eyelet 70into the bone hole. Once inserted in the bone hole, the resiliency ofthe wings forces them back to the expanded state whence they anchor theeyelet 70.

FIG. 6 shows another one-piece eyelet 80 according to the invention. Theeyelet 80 includes head 82, body 84 and cannula 85. The head 82 isflanged to prevent the eyelet 80 from being pushed too far into the bonehole 86 by suture 88. The cannula 85 permits passage of the suture 88through the eyelet. Unlike eyelet 70 described above, eyelet 80 does notinclude wings at its distal end. Rather eyelet 80 is held by simpleinterference fit with the curved walls of hole 86, as shown.

FIG. 7 shows yet another one-piece eyelet 90 constructed like eyelet 80,except for inclusion of spiral threads 92 on the body of the eyelet.These threads permit eyelet 90 to be screwed into bone hole 94, asshown.

The eyelets shown in FIG. 4-7 are comprised of a biocompatible materialssuch as implant grade high density polyethylene, low densitypolyethylene (PE 6010 and PE 2030) and polypropylene (13R9A and 23M2:all made by Rexene, Dallas, Tex.). The eyelets may also be comprised ofa metal, such as, surgical implant grade stainless steel.

Described above are methods and apparatus meeting the objects set forthabove. Those skilled in the art will appreciate that the illustratedembodiments are shown and described by way of example only, and thatother methods and apparatus incorporating modifications therein fallwithin the scope of the invention. For example, in addition to rotatorcuff repair, the invention can be beneficially applied in connectionwith other soft tissue-to-bone attachments utilizing transosseoustunnels, such as (by way of nonlimiting example) distal biceps tendonrepair, scapho-lunate ligament repair and dorsal capsulodesis, DRUJarthroplasty, reconstruction RCL/UCL of the thumb, reconstructionRCL/UCL of the fingers, repair of central siip for Boutonniere deformityof the hand, repair of terminal tendon for Mailet deformity of the hand,repair of avulsed or lacerated FDP/FDS, repair of ATF/CF ligaments tocorrect lateral ligamentous instability of the ankle/foot, achillestendon repair following tear, bifurcate ligament repair to correctavultion of anterior lateral calcaneous.

In view of the foregoing, what we claim is:
 1. In a method for attaching soft tissue to bone by passing a suture through a transosseous tunnel in the bone and affixing the soft tissue with the suture, the improvement, comprising the steps ofA. reinforcing an opening at an end of the tunnel by placing an eyelet into the end of the tunnel, the eyelet having an channel extending therethrough; B. passing the suture through the channel of the eyelet, as well as through the transosseous tunnel, in order to affix the soft tissue to the bone with the suture.
 2. In a method for rotator cuff repair by attaching the spinatus tendon to the humerus by passing a suture through a transosseous tunnel in the bone and affixing the soft tissue with the suture, the improvement comprising the steps ofA. reinforcing an opening at an end of the tunnel by placing an eyelet into an end of the tunnel, the eyelet having an channel extending therethrough; B. passing the suture through the channel of the eyelet, as well as through the transosseous tunnel, in order to affix the soft tissue to the bone with the suture.
 3. In a method according to any of claims 1 and 2, the further improvement comprising screwing the eyelet into bone at the end of the tunnel.
 4. In a method according to any of claims 1 and 2, the further improvement comprising affixing the eyelet into bone at the end of the tunnel by interference fit.
 5. In a method according claim 2, the further improvement comprising expanding an opening at the end of the tunnel prior to placing the eyelet therein.
 6. In a method for attaching soft tissue to bone by passing a suture through a transosseous tunnel and affixing the soft tissue with the suture, the improvement comprisingA. reinforcing a bone opening at an end of the tunnel by placing an expandable member into the bone opening at the end of the tunnel, the expandable member having an channel extending therethrough; B. inserting an insertion element into the channel of the expandable member, the insertion element including an channel extending therethrough, at least a portion of the insertion element including an outer diameter greater than an inner diameter of the channel at least a portion of the expandable member for expansion thereof upon engagement therewith, whereby, inserting the insertion element into the expandable member causes expandable member to expand to obtain a pressure fit with the bone opening; and C. passing the suture through the channel of the insertion element, as well as through the transosseous tunnel, in order to affix the soft tissue to the bone with the suture.
 7. In a method for attaching soft tissue to bone by passing a suture through a transosseous tunnel and affixing the soft tissue with the suture, the improvement comprisingA. reinforcing a bone opening at an end of the tunnel by placing a substantially cylindrical expandable member into the bone opening at the end of the tunnel, the expandable member having an axial channel extending between its proximal and distal ends; B. inserting an elongate insertion element into the channel of the expandable member, the insertion element including an axial channel extending between its proximal and distal ends, at least a portion of the insertion element including an outer diameter greater than an inner diameter of at least a portion of the axial channel of the expandable member for expansion thereof upon engagement therewith, whereby, inserting the insertion element into the expandable member causes expandable member to be to expand to obtain a pressure fit with the bone opening; and passing the suture through the axial channel of the insertion element, as well as through the transosseous tunnel, in order to affix the soft tissue to the bone with the suture.
 8. In a method according to any of claims 6 and 7, wherein the method is adapted for rotator cuff repair, the further improvement wherein the placing step includes the step of placing the expandable member into an end of a transosseous tunnel in the humerus.
 9. In a method according to any of claims 6 and 7, the further improvement comprising using an emplacement element to place an expandable member into the end of the bone opening.
 10. In a method according to claim 9, the further improvement wherein the expandable member being frangibly attached to the emplacement element.
 11. In a method according to claim 10, the further improvement whereinthe inserting step includes applying force to the insertion element, and the method comprises breaking the frangible attachment between the expandable member and the emplacement element by applying force to the insertion element subsequent to expansion of the expandable member in the bone opening.
 12. In a method according to claim 11, wherein the method is adapted for rotator cuff repair, the further improvement wherein the placing step includes the step of placing the expandable member into an end of a transosseous tunnel in the humerus.
 13. In a method for attaching soft tissue to bone by passing a suture through a transosseous tunnel and affixing the soft tissue with the suture, the improvement comprisingA. reinforcing a bone opening at an end of the tunnel by using an emplacement element to place an expandable member into the bone opening at the end of the tunnel, the expandable member having an channel extending therethrough, the expandable member being frangibly attached to the emplacement element; and B. applying a compressive force to said expandable member to expand its channel so that an outer surface of said expandable member engages with the bone; and C. breaking the frangible attachment between the expandable member and the emplacement element, and removing the emplacement element; and D. passing the suture through the axial channel of the insertion element, as well as through the transosseous tunnel, in order to affix the soft tissue to the bone with the suture.
 14. In a method according to claim 13, the further improvement comprising applying the compressive force to the expandable element by inserting into the channel thereof an insertion element including an outer diameter greater than an inner diameter of at least a portion of the channel of the expandable member for expansion thereof upon engagement therewith.
 15. In a method according to any of claims 13 and 20, wherein the method is adapted for rotator cuff repair, the further improvement wherein the emplacement element is used to place the expandable member into an end of a transosseous tunnel in the humerus.
 16. In a method for attaching soft tissue to bone by passing a suture through a transosseous tunnel in the bone and affixing the soft tissue with the suture, the improvement comprising the steps ofA. reinforcing an opening at an end of the tunnel by placing an eyelet into the end of the tunnel, the eyelet including a body disposed within the tunnel and a flanged head that protrudes above a surface of the bone, the eyelet further having an channel extending therethrough; B. passing the suture through the channel of the eyelet, as well as through the transosseous tunnel, in order to affix the soft tissue to the bone with the suture.
 17. In a method according to any of claims 16 and 17, the further improvement comprising screwing the eyelet into bone at the end of the tunnel.
 18. In a method according to any of claims 16 and 17, the further improvement comprising affixing the eyelet into bone at the end of the tunnel by interference fit.
 19. In a method for attaching soft tissue to bone by passing a suture through a transosseous tunnel and affixing the soft tissue with the suture, the improvement comprisingA. reinforcing an opening at an end of the tunnel by placing an expandable member into an end of the bone opening, the expandable member including a body disposed within the tunnel and a flanged head that protrudes above a surface of the bone, the expandable member further including an channel extending therethrough; B. inserting an insertion element into the channel of the expandable member, the insertion element including an channel extending therethrough, at least a portion of the insertion element including an outer diameter greater than an inner diameter of the channel at least a portion of the expandable member for expansion thereof upon engagement therewith, whereby, inserting the insertion element into the expandable member causes expandable member to expand to obtain a pressure fit with the bone opening; and C. passing the suture through the channel of the insertion element, as well as through the transosseous tunnel, in order to affix the soft tissue to the bone with the suture.
 20. In a method for attaching soft tissue to bone by passing a suture through a transosseous tunnel and affixing the soft tissue with the suture, the improvement comprisingA. reinforcing an opening at an end of the tunnel by placing a substantially cylindrical expandable member into an end of the bone opening, the expandable member including a body disposed within the tunnel and a flanged head that protrudes above a surface of the bone, the expandable member having an axial channel extending between its proximal and distal ends; B. inserting an elongate insertion element into the channel of the expandable member, the insertion element including an axial channel extending between its proximal and distal ends, at least a portion of the insertion element including an outer diameter greater than an inner diameter of at least a portion of the axial channel of the expandable member for expansion thereof upon engagement therewith, whereby, inserting the insertion element into the expandable member causes expandable member to be to expand to obtain a pressure fit with the bone opening; and C. passing the suture through the axial channel of the insertion element, as well as through the transosseous tunnel, in order to affix the soft tissue to the bone with the suture.
 21. In a method according to any of claims 18 and 20, wherein the method is adapted for rotator cuff repair, the further improvement wherein the placing step includes the step of placing the expandable member into an end of a transosseous tunnel in the humerus.
 22. In a method according to any of claims 18 and 20, the further improvement comprising using an emplacement element to place an expandable member into the end of the bone opening.
 23. In a method according to claim 22, the further improvement wherein the expandable member being frangibly attached to the emplacement element.
 24. In a method according to claim 23, the further improvement wherein the inserting step includes applying force to the insertion element, and the method comprises breaking the frangible attachment between the expandable member and the emplacement element by applying force to the insertion element subsequent to expansion of the expandable member in the bone opening.
 25. In a method according to claim 24, wherein the method is adapted for rotator cuff repair, the further improvement wherein the placing step includes the step of placing the expandable member into an end of a transosseous tunnel in the humerus. 